Expanding Access to Buprenorphine

aaaabalance

My last blog post stimulated some lively debate, and I thought this topic deserved further discussion. However, I would like to ask commenters to talk about the issue and please refrain from mentioning specific names of previous commenters. Please and make your points in a thoughtful and respectful manner. Thanks for your cooperation.

Given our present epidemic of opioid addiction and opioid overdose deaths, authorities are considering lifting the 100-patient limit for physicians who prescribe buprenorphine from office-based settings. Some people in the addiction treatment field oppose expanding access to buprenorphine in the office setting, saying some of these patients don’t get the counseling that they need, but only medication. They say there aren’t enough regulations to prevent shady physicians from opening buprenorphine mills.

Experts on both sides of the debate make good points. It’s a tough topic, but let’s explore the issues further.

1. “You don’t provide enough counseling.”

Weirdly, this used to be a main complaint against OTPs, but now OTP personnel are directing the same complaint toward office-based buprenorphine physicians.

Is there any data to help us decide how much counseling is enough for opioid-addicted patients who are started on medication, either buprenorphine or methadone?

The POATS trial gives some information on this topic. (Weiss et al, 2010, http://ctndisseminationlibrary.org/protocols/ctn0030.htm )

POATS showed that opioid-addicted patients maintained on buprenorphine/naloxone were likely to reduce illicit opioid use during treatment with the medication, but most relapsed after being tapered off the medication at twelve weeks. So this part of the study supported keeping patients on medication longer, just like the older data with methadone for heroin users. No surprises so far.

Now comes the interesting part: POATS showed similar outcomes for patients getting standard medical management versus standard medical management plus fairly intense counseling. The group with added counseling didn’t do any better than the standard medical management group.

However, the standard medical management consisted of an hour-long first visit with the doctor, and a fifteen- to twenty- minute visit per week for the first four weeks, then every two weeks.
This may be more than an average buprenorphine doctor provides in real life. It’s a little more than I do for my office-based patients. My first visit with new patients is one hour, and usually I see them back in one week for a twenty-minute visit. But then, if they are doing well, I see them every two weeks, until the patient is established in counseling. After that, if all is going well, I cut down to monthly visits. I conclude that the average buprenorphine doctor may have to increase visit frequency to get the results seen in the POAT study.

The group with enhanced counseling treatment got 45 minutes with a counselor twice per week for the first four weeks, then twice per month. At present, patients of OTPs must have two counseling sessions per month, even at the beginning of treatment. Opioid clinic opponents say twice per month isn’t even close to enough counselling, and use this point as a reason to say opioid treatment programs deliver bad care.

The POAT study was relatively short. Twelve weeks may not be long enough to detect an improvement in patients getting enhanced counseling. We know life changes usually don’t happen quickly. Maybe it is unfair to say the counseling didn’t help, because the patients weren’t followed long enough.

Now let’s look at interim methadone. Interim methadone was proposed as an alternative to long waiting lists for patients to enter an opioid treatment program. People were concerned about the welfare of opioid addicts who wanted help, but had to wait for a treatment slot to open. Interim methadone is a short-term, simplified treatment where methadone medication is started for the opioid addict, until the patient can be admitted to an OTP. With interim methadone, some counseling given, but only for emergency situations. Drug screening is still done, but is more limited than for OTP patients. These interim patients can transition to a traditional opioid treatment program when a slot opens for them.

It appears that starting just methadone, with limited other services, still helps the patients. Studies show these patients are less likely to continue to use heroin, are less likely to commit crimes, and more likely to enter a full-service OTP when admission is offered. [1]

Would “interim buprenorphine” work as well? I don’t think there are any studies to give us data, but it seems logical that it would.

2. “Just apply to be an OTP”

Government officials have said that if office-based physicians wish to see more than one hundred buprenorphine patients, the physician should apply to become an opioid treatment center.

When I first read this suggestion, I laughed, because it sounded so silly to me. Well-intentioned though this statement might be, it starkly exposed a lack of knowledge of the average physician’s economic circumstances.

I don’t know many doctors like me who have the necessary capital to do this. Some professionals in the field estimate it takes starting capital of around a quarter of a million dollars. I’ve seen one OTP fold due to inadequate financial support and management, and another escape closure by a narrow margin. These days, it takes deep pockets to afford the eighteen to twenty-four month process to establish an OTP. Getting the certificate of need alone can take years. (Just look at Crossroad’s struggles to get a CON in Eastern Tennessee, an area with arguably more opioid addiction per capita than most other states!)

OTP sites must be approved by multiple agencies: the DEA, CSAT, SOTA, and local authorities to name a few. The pharmacy has to meet strict regulations, as do personnel. If you want to accept Medicaid, that’s another avalanche of regulation and paperwork.

I’m not saying it’s impossible for a physician to open an OTP, but I am saying that it would cost so much that most doctors who treat opioid addiction wouldn’t consider it. I could be wrong – maybe my colleagues are making a whole lot more than me…

3. “In it for the money.”

Experts in the field who work for opioid treatment programs oppose expansion of office-based treatment, saying doctors charge exorbitant fees for their patients. Sadly, in some cases, they are right. But many office-based doctors charge reasonable fees. If we allowed doctor to treat more than one hundred opioid-addicted patients at one time with buprenorphine, wouldn’t that reduce demand for services? And when demand decreases, shouldn’t cost of treatment drop too?

For example, let’s take a community where one buprenorphine doctor is price gouging, and charging $500 per month for only one doctor’s visit. The second buprenorphine doctor charges $250 per month for the same service plus addiction counseling. Both are at their one- hundred patient limit. If both were allowed to increase the number of their patients, wouldn’t the second, more reasonably-priced doctor get some of the more expensive doctor’s business?

Conversely, some advocates for office-based treatment say that opioid treatment programs are upset because they have lost money in recent years. They accuse organizations like AATOD of wanting to limit further expansion of office-based programs because it cuts into their business. With more access, more patients would abandon OTPs for these less restrictive programs

DATA 2000 changed the landscape of opioid addiction treatment. OTPs aren’t the only option for patients seeking treatment for their opioid addiction.

My point is, both OTPs and buprenorphine doctors can accuse the other group of being in it for the money. But as I pointed out in my last blog…no medical treatment in this country is free.

4. “My medication is better than your medication.”

Patients entering opioid addiction treatment often ask me, “Which is better, buprenorphine or methadone?” I say, “Both.” Each has its advantages, and I’ve discussed this in previous blog entries. Briefly, buprenorphine is safer, since there is a ceiling on its opioid effects, but it’s more expensive. Patients on buprenorphine also seem to leave treatment prematurely more often than methadone patients. This isn’t a good thing, since the majority of these patients relapse back to illicit opioid use.

Methadone, as a full opioid agonist, may be more difficult to taper off of, and maybe fewer patients leave treatment prematurely because of that feature. Methadone has been around for fifty years now, with a proven track record. It works, and it’s dirt cheap. Methadone does have more medication interactions, but those can usually be managed if all the patient’s doctors communicate with each other.

Buprenorphine isn’t strong enough for all opioid addicts. Because it’s a partial agonist, there’s a ceiling on its opioid effect. This property means it’s much safer than methadone, but it doesn’t work for everyone.

Buprenorphine is safer than methadone, which to me is its best quality. I’ve started hundreds of patients on buprenorphine and never had an induction death. Sadly, I cannot say the same of methadone. I am not saying overdose death is impossible with buprenorphine…I’m saying it’s much less likely, and that’s worth a lot to me.

Buprenorphine’s superior safety profile is one reason it was approved for use in an office setting. Methadone is riskier to prescribe from an office, because misuse and diversion is more likely to be fatal with this drug. That’s why buprenorphine has fewer restrictions on it. Neither medication is good or bad; the difference between the medications is pharmacologic, not moral.

Next week, I’ll describe my OTP, where we provide methadone, buprenorphine under the OTP license, and buprenorphine under my office-based license, all on the same premises. I think we’ve created a continuum of care that’s able to meet the needs of patients as their recovery evolves.

At our program, it’s not one program versus another. Difference patients need different things, and the same patient may need different things at different points in recovery.

1. Schwartz et al, “A Randomized Control Trial of Interim Methadone,” Archives of General Psychiatry, 2006

Advertisements

12 responses to this post.

  1. Posted by Elizabeth on October 27, 2014 at 12:34 am

    Thank you for this blog entry Dr. Burson. You’ve highlighted exactly every point that I was also trying to make in discussing this with many people. I have a great doctor who runs an awesome office based program for opioid addiction, and I’ve been stable and doing well for a bit over a year, and neither I nor my doctor would likely be effected by more restrictions. However, I am so strongly in favor of lifting the 100 patient cap because I care about fellow addicts in need of help. To give you an example of what I mean ; occasionally I run into an old friend or acquaintance from my old using days, and they’re still using. Sometimes, they’ll tell me “you look so great, I’m so proud of you for getting out, I wish I could.” Then they’ll ask “What doctor do you go to? Is he taking new patients? ” Sadly, at this point I say “No, but have you tried finding a doctor at the buprenorphine physician locator websites?” The usual response is; “oh yeah, but none of the ones I called are taking anyone right now, but I’m on a bunch of waiting lists. ” At this point we depart, and since I no longer associate with people who use unless I accidentally run into someone, I wonder what will become of that person. It makes me sad that I can’t help them or say, “yeah, my doctor has openings, here’s his number.” I want others to be able to get the treatment they desperately need and want, the treatment that saved my life, and allows me to continue to be healthy and happy again. I think that lifting or raising the cap would accomplish this.

    About the argument that a physician could just apply to be an OTP, even assuming it’s financially feasible for him to do so, I like being treated in the privacy of a doctor’s office, and chose this treatment because it could be provided in a doctor’s office, and I’m sure I’m not the only one who likes this option. I would choose not to go to an OTP. Is it fair for good doctors who are capable of treating more than 100 patients to have to become an OTP to treat more? I say no.

    Thank you for addressing this extremely important issue. It’s so important, that the sooner lifting the cap can happen, the better. Before any more people die on a waiting list.

    Reply

  2. I provide counseling services to buprenorphine patients in the office of a psychiatrist. My experience is that some patient and family education about the recovery process and buprenorphine treatment, and counseling to mitigate crises, along with prescribing buprenorphine in such a way as to gradually limit addictive patterns is helpful to patients early on in treatment. Initially most patients don’t understand the benefits of counseling and education it in this situation. Is important for us to assert that we know better. This also helps to establish what can become a long term therapeutic relationship where we can work together with the patient as he or she becomes more ready to make changes occur in the process of recovery. Increasing and decreasing frequency as needed is cost effective but allows for continued contact, and that is very important. Counseling is particularly valuable as the patient moves towards decreased dosages. Unfortunately there is no quick fix for this population but I think that these strategies provide the best outcomes.

    Reply

  3. Posted by 1x2s on October 27, 2014 at 3:11 pm

    I’ve been on methadone 20 years. In terms of real experiences have have seen it all.People can understand what war is by reading a book,classroom,or from being told by a soldier who was on the battle field. Only a junky who has gone in neighborhoods to by dope knows the dangers. These junkies are adrenaline junkies too. Who goes to places to buy heron and may encounter being robbed,killed,arrested,and jail time. Just to name a few examples. ONCE A JUNKY HITS BOTTOM. Most are homeless,dirty,have no friends and a lot of their families have turned away.SELF DESTRUCTION SOME AND OTHERS IT IS THE THRILL OF THE HUNT.OF course all like the high . WHEN a junky is on a run they know or think they can pull up their plane before it hits and burns .By some miracle the junkies plane will RIGHT IT SELF AND BE BACK UP IN THE CLOUDS WITH THE SUN TO THEIR BACKS. A junky could be a young person from a family of fame and riches ,middle class or from the poorest side of town.All of the above social classes have been found dead OD ,OR ARRESTED .NO COUNSELING IS GOING TO STOP THE JUNKY UNTIL THE TIME THE JUNKY SEES WHAT A A SELFISH PERSON HE HAS BECOME AND THE PAIN HE BROUGHT TO FAMILY AND FRIENDS.ADDICTION IS SO HARD TO CURE AND NEVER WILL BE. The people who only understand war from reading about it in a book. Are the people that make up methadone programs and other drug programs have only institutionalize the junky. Who from the AMA to federal ,state, government would give a addicted person a drug that is harder to withdraw than heron or the drug of choice of the addicted. The methadone program is life saving .I have been a functioning junky and worked for 37 years. I believe truly that people who care for the addicted be gambling,booze,sex, even chocolate cake. we who care can make a drug to help cure the junky without a withdraw that takes months and feel like GOD has pimp slapped us .to be continued. P.S.junkies are manipulative and cameras should be in all clinics,except the bathrooms.

    Reply

    • Eww. I have a visceral reaction to the term “junky.” It’s pejorative. Not all the patients I see with opioid addiction have lost everything. Thankfully, some opioid addicts don’t wait until they lose all. Some are able to have enough insight to see they need help and are able to get into treatment earlier in the course of the disease.

      Reply

  4. Posted by Jeff on October 28, 2014 at 12:57 am

    Has anyone stopped to wonder why diversion of Bup is as high as it is? I’ve not seen anywhere that Bup is the most abused drug. I just have not. On its face the supply is just not there. There is simply way more heroin coming onto the streets than Bup. The great majority of black market Bup is used to head off withdrawals – not get high. Raising the cap is likely to reduce diversion or at least level it off as addicts have the ability to get it legally rather than on the street – which currently my be their only choice! No addict is after Bup to get high – they just are not. They want heroin or full agonist opiates to get high and Bup to get well.

    I also find it beyond crazy that a pain management doc can have 500 or more patients on oxy but only 100 on Bup. Government screws up everything they put their hands on. The examples are far and wide. Government and regulations are not the answer to the problem – THEY ARE THE PROBLEM, allowing elected officials to practice medicine will only make things worse. Rather than out chasing actual drug dealers the DEA is in doctor offices doing Bup audits to make sure no doc has more than 100 patients!

    And we wonder why we are in the mess we are. How crazy is it that Bup is the only medication in the entire flipping USA that limits how many patients a doctor can have on it. On top of all if this, it won’t matter how many patients a doctor sees each day, week, or month when insurance and other restrictions essentially limit the time spent with the patient to 5 or 10 minutes.

    Some people see this and now argue that doctors should only be allowed to have 100 patients on oxy as well. They then argue insurance should be forced to pay for a doctor to spend the appropriate amount if time with each patient OR jut force the doc to do it for no extra pay. They want to hire even more DEA agents so they can check up on even more doctors. This is the answer that half of the USA wants – BIGGER GOVERNMENT. Others, like myself just want the government to get the hell out of the way. Bup is very clearly helping more than it is hurting. It just is. Nothing is perfect but we are better off and more people are helped with Bup than were without it. Treating this drug like no other in the USA is crazy. We’ve been at the 100 patient cap for about 8 years now while the need is shooting through the roof.

    As I said in another reply – people’s lives are at risk here. People die each day because the United states government won’t allow doctors to treat them with a safe, effective and proven treatment. If this is not healthcare rationing right before our eyes I don’t know what is!

    Reply

  5. Posted by Rick Smith on November 2, 2014 at 6:16 pm

    Thank you for everything you do. My friend who is 71 has been on 10mg oxycodone 2 times daily for a year for throut pain, from her primary MD. Turned out to be cancer and she just had surgery and has to use a feeding tube now. She told her MD she was having to take !0mg oxy 3 times a day since surgery, he called her a drug addict and gave her one last script for 30 pills and sent her to a pain clinic. The Dr. gave her 4/1 suboxone to take 4 times daily. She thought it was for pain and with no information from the Sub Dr. took one while still taking the oxy. Of course she went into precipitated withdraw for over a day, I didn’t know what to do but take care of her. This Sub Dr is negligent as I see it for not telling her to wait 3 or 4 days after she runs out of the oxy. Can I report him, I want to confront him because she has no reason to even be on Subs as she is CPP not a drug addict.

    Reply

    • Yes. You can ask your friend to file a complaint to your state’s medical board. They will ask for records from these two doctors to determine if they acted inappropriately. I don’t think you can report these doctors since you were not the patient. They have to hear from the person to whom this happened.

      Reply

      • How many more people have to die before we expand treatment. The PMP having many patients without a doctor and they are opioid dependence or addiction did not get treated. They are new heroin users. Their children who stole there medication are also still in need of treatment or End up dead from a heroin overdose,

  6. Posted by Dan Woodard MD on January 16, 2016 at 4:13 am

    Excellent points. I don’t personally ever want to see more than 100 patients, but I don’t feel the one year waiting period before one can see more than 30 patients makes no sense. As a board certified ER doc I have been making spot judgments and prescribing or denying opiates for 30 years. In a month in residency you learn how to respond to cardiac arrest. It takes at most three months of seeing 30 patients to be comfortable with up to 100. Several of my current patients have been through OTPs and although they were often of temporary benefit most patients relapse after leaving the program.

    OTPs are obviously much too expensive to be available to even a fraction of the people who need them, and more resources are needed for prevention. An understanding of opioid dependence needs to be part of the training of _every_ doctor who prescribes opiates, and the treatment, if needed, needs to be integrated into the lifelong treatment of all the patient’s problems by the properly trained primary care physician.

    Suboxone is a remarkably, even astonishingly effective drug. It is indeed habituating and is far from innocuous but every single patient has taught me that it is much safer than opiates. This whole area suggests to me that many physicians are more concerned about their incomes than their patietns’ care.

    Reply

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: